• 의학교육논단
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• 제22권1호
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• pp.32-45
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• 2020

This narrative review introduces global trends in pharmacovigilance (PV) education for healthcare professionals and the status of PV education in Korea. Proactive participation of healthcare professionals, including physicians, pharmacists, and nurses in reporting suspected adverse events is the main driving force for effective operation of the spontaneous adverse event reporting system database, which in turn facilitates early safety signal detection of otherwise unknown suspected adverse events. The World Health Organization recognizes PV education curriculum as a key aspect in promoting awareness of PV and adverse event reporting among healthcare professionals, and multiple studies have demonstrated that PV educational interventions for healthcare professionals have increased overall adverse event reporting. Considering the global trends in PV education, the curriculum in Korean universities still has room for improvement in promoting PV obligation among future healthcare professionals. Further research is needed to develop PV education curriculum. We suggest a three-step project for innovating PV education in Korea to meet the global PV educational standards: a survey to gauge current PV competencies among healthcare professionals, reform of current PV academic curriculum, and evaluation and fine-tuning of the reformed curriculum.

• 한방재활의학과학회지
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• 제24권4호
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• pp.97-109
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• 2014

Objectives Bee venom acupuncture (BVA) is emerging as a potential therapeutic option for several conditions. However, evidence regarding accurate estimates of its adverse events are not available. Therefore, by combining occurrence rates of adverse events in relevant randomized controlled trials (RCTs), we have aimed to give an overall estimated rate of each adverse event following BVA intervention. Methods A systematic search for adverse events of BVA in Pubmed, Cochrane Central Register of Controlled Trials, Embase, NDSL, KoreaMed, KISS, RISS, KISTI, and KMbase was performed. For the quality assessment of the trials, we applied the CONSORT harms reporting recommendations. The overall occurrence rate of each adverse event was assessed as the primary outcome. The overall drop-out rate due to adverse events was assessed as the secondary outcome. Results Ten RCTs reported adverse events following BVA. Two RCTs were eligible of further synthesis. Adverse events of pruritus, localized edema, and erythema occurred significantly more frequently in the BVA group compared to the control group. Data of drop-outs were available in seven RCTs. However, no comparisons showed a significant difference. Conclusions Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. Still, limited evidence shows a tendency that adverse events occur more frequently after the appliance of BVA compared to the control. Thus, we await well designed future studies of BVA with more proper and strict harms reporting methods.

• 한국의료질향상학회지
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• 제21권1호
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• pp.66-76
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• 2015

Objectives: The purpose of this study is to develop a case review form for detecting adverse events through a medical records review in hospitalized patients in South Korea. Methods: To develop the case review form, several literatures were reviewed, first. Through the clinical expert meeting, screening criteria were selected and case review form was developed. Result: The Korean version of case review form consisted of the review form-1 for adverse event screening and form-2 for adverse event identification. The applied methodology for the case review form is determined according to the previous studies. For example, the method used in the first stage review is nurse review. Furthermore, the National Coordinating Council for Medication Errors Reporting and Prevention index is used to categorize disability, and a scale of 1 to 6 was used in the causation scores and preventability scores, respectively. Through the clinical expert meeting, a total of 41 screening criteria were selected. Conclusion: The Korean specific case review form was developed for detecting adverse events in hospitalized patients. The results from this study can be used in a large-scale study regarding the nationwide incidence of adverse events.

• 한국의료질향상학회지
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• 제22권2호
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• pp.43-73
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• 2016

Purpose: The aims of this study were to assess the presence of core patient safety practices in Korean hospitals and assess the differences in reporting and learning systems of patient safety, infrastructure, and safe practices by hospital characteristics. Methods: The authors developed a questionnaire including 39 items of patient safety staffing, health information system, reporting system, and event-specific prevention practices. The survey was conducted online or e-mail with 407 tertiary, general and specialty hospitals. Results: About 90% of hospitals answered the self-reporting system of patient safety related events is established. More than 90% of hospitals applied incidence monitoring or root cause analysis on healthcare-associated infection, in-facility pressure ulcers and falls, but only 60% did on surgery/procedure related events. More than 50% of the hospitals did not adopted present on admission (POA) indicators. One hundred (80.0%) hospitals had a department of patient safety and/or quality and only 52.8% of hospitals had a patient safety officer (PSO). While 82.4% of hospitals used electronic medical records (EMRs), only 53% of these hospitals adopted clinical decision support function. Infrastructure for patient safety except EMRs was well established in training, high-level and large hospitals. Most hospitals implemented prevention practices of adverse drug events, in-facility pressure ulcers and falls (94.4-100.0%). But prevention practices of surgery/procedure related events had relatively low adoption rate (59.2-92.8%). Majority of prevention practices for patient safety events were also implemented with a relatively modest increase in resources allocated. Conclusion: The hospital-based reporting and learning system, EMRs, and core evidence-based prevention practices were implemented well in high-level and large hospitals. But POA indicator and PSO were not adopted in more than half of surveyed hospitals and implementation of prevention practices for specific event had low. To support and monitor progress in hospital's patient safety effort, national-level safety practices set is needed.

• 한국컴퓨터정보학회논문지
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• 제14권3호
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• pp.183-192
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• 2009

약물부작용감시시스템 (Adverse drug event surveillance system)은 약물부작용신호를 이용하여 약물의 부작용 여부를 식별하는 시스템이다. 기존의 자발적 보고나 차트리뷰 보다 효율성이 뛰어난 시스템으로 분류할 수 있다. 본 논문에서는 약물부작용감시시스템을 구현하기 위하여 임상데이터마트(GDM)를 구축하였다. 특히, 데이터 품질관리 기법을 적용하여 구축된 CDM에 지식 탐사 기법 중 비교사학습 기법으로 적용하여 모델의 재현성을 평가하여 최적의 약물부작용 군집화 개수(n=4)를 도출하였다. 군집화 개수(n=4)를 이용하여 약물부작용 판별을 위한 K-means, Kohonen, two-step clustering model 알고리즘에 적용하여 분석함으로써 K-means 알고리즘이 가장 우수한 군집 효과를 나타냄을 확인하였다.

• 대한본초학회지
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• 제36권5호
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• pp.69-79
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• 2021

Objectives : In clinical practice, there are many cases of co-administration of herbal medicine and synthetic drugs. This study tried to identify whether the combined administration of herbal medicine and synthetic drugs including amoxicillin increases Helcicobacter pylori eradication rate compared to the single administration of synthetic drugs or the combined administration of synthetic drugs and placebo herbal medicine through systematic review. Methods : Relevant randomized controlled trials were searched in PubMED database. The risk of biases was assessed through the Cochrane Risk of Bias criteria. Three reviewers were extracted the characteristics and outcomes of each study. Meta-analysis of eradication rate and adverse event was conducted. Results : Four RCTs were selected. In meta-analysis, the combination of herbal medicine and synthetic drugs showed eradication effect, but it was not statistically significant (Odds Ratio [OR] 0.46; 95% confidence interval [CI] 0.17 to 1.24; p=0.13; I²=56%) than administration of synthetic medicine alone. Combination of herbal medicine and synthetic medicine did not increased the incidence of adverse event(OR 1.07; 95% CI 0.72 to 1.59; p=0.68, I²=0%) compared to single administration of synthetic medicine. Conclusion : Although no significant difference was observed between the two groups in the eradication rate and the incidence rate of adverse events, it was difficult to draw a clear conclusion due to the heterogeneity between studies and the low quality of reporting. A number of studies that have overcome these limitations in the future will lead to definite conclusions.

• 대한치과교정학회지
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• 제51권3호
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• pp.199-216
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• 2021

Objective: The aim of this systematic review was to evaluate the complications and side effects associated with the clinical use of orthodontic miniscrews by systematically reviewing the best available evidence. Methods: A survey of articles published up to March 2020 investigating the complications associated with miniscrew insertion, in both the maxilla and mandible, was performed using 7 electronic databases. Clinical studies, case reports, and case series reporting complications associated with the use of orthodontic miniscrew implants were included. Two authors independently performed study selection, data extraction, and risk-of-bias assessment. Results: The database survey yielded 24 articles. The risk-of-bias assessment revealed low methodological quality for the included studies. The most frequent adverse event reported was root injury with an associated periradicular lesion, vitality loss, pink discoloration of the tooth, and transitory loss of pulp sensitivity. Chronic inflammation of the soft tissue surrounding the miniscrew with mucosal overgrowth was also reported. The other adverse events reported were lesion of the buccal mucosa at the insertion site, soft-tissue necrosis, and perforation of the floor of the nasal cavity and maxillary sinus. Adverse events were also reported after miniscrew removal and included secondary bleeding, miniscrew fracture, scars, and exostosis. Conclusions: These findings highlight the need for clinicians to preliminarily assess generic and specific insertion site complications and side effects.

• 대한한의학회지
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• 제45권1호
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• pp.165-181
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• 2024

Objectives: This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea. Methods: This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO's global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed. Results: Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death. Conclusions: This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.

• 한국임상약학회지
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• 제21권4호
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• pp.383-389
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• 2011

약물요법에 있어 약물이상반응은 환자의 사망률과 이환율에 영향을 미치는 중요한 요인이다. 약물이상반응 발생시 이를 신속히 보고하는 것과 함께 약물치료과정에서 일어날 수 있는 약물 관련부작용을 조기에 인지하고 능동적으로 조치함으로써 환자에게 가해지는 위해를 최소화하는 것 또한 실제 환자치료의 질적인 관리에서 중요한 부분이다. 본 연구에서는 의료기록의 전산화에 따른 전산데이터들을 활용한 약물이상반응감시방법 중 하나로 평가 받고 있는 Computerized surveillance system (CSS)에 대한 사례 연구들의 방법들을 비교해 보고, 제시된 관련 시그널들 중 약물이상반응을 능동적인 방법 즉 실시간 혹은 예방적으로 적용 가능한 시그널들을 찾아 정리해 보고자 하였다. 이를 위해 가장 대표적인 연구가 진행되었던 연구사례들을 분석하였고 약 20여 개의 시그널들을 선정하여 분야별로 제시하였다.

• 대한의용생체공학회:의공학회지
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• 제41권1호
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• pp.35-41
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• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.